1. Field of the Invention
The present invention relates to systems, processes and tools for management of human body solid, liquid and gaseous wastes, including collection bags and other tools used for minimizing personal negatives for people who must use collection bags of the kind having an inlet aperture for connection of the bag directly or indirectly to a person's skin surrounding a surgically established waste outlet commonly referred to as a stoma.
2. Background Art
A stoma, an outlet through the abdominal wall, is created, for example, during surgery for an intestinal disorder, such as colon cancer, in which it had been necessary to remove or otherwise incapacitate the patient's rectum, leaving the patient without the natural means for controlling waste discharge. Collection bags for attachment to the human body for collecting body wastes are often referred to as ostomy bags (or as ostomy pouches). People who have had an ileostomy or colostomy find it necessary to use the bags to help manage their uncontrolled discharge of flatus gas, liquid and fecal solid material.
Several different designs of ostomy bags are commercially available. Many are pictured in miniaturized outline form and described in detail in commercial catalogs, for example, from Edgepark Surgical, of Twinsburg, Ohio, a company that sells ostomy products from several different manufacturers. Commercially available ostomy bags come in various sizes and shapes generally ranging from about 10 to 15 cm (4 and one half to 6 in.) wide, and about 10 to 25 cm (6 to 10 inches) long, or even longer if the bag has a discharge channel. Such bags usually comprise a body-side wall (i.e. intended to face, be nearer to, the user's body, sometimes referred to herein as the proximal wall or rear wall) and an opposing frontal-side wall (sometimes referred to herein as the distal wall or frontal wall). Each of these walls normally has a base that is a gas- and liquid-impermeable, heat sealable thermoplastic material. The internal surfaces of the frontal-side and body-side wall materials are sealed to each other at or near their perimeters, thus defining an interior chamber of the bag between the walls. The proximal walls of commonly used bags have near the top of each bag (as it is worn by the user) a circular stomal aperture. In a bag referred to as a two piece bag, that aperture is circumscribed by a relatively firm plastic ring, for attachment to a mating ring of an ostomy wafer that is adhesively attached to the skin surrounding the stoma. The attachment of the two rings is intended to provide a liquid and gas impermeable junction. One of the most common attachments uses a protruding, male circular ring member on the ostomy wafer and a female circular recess on the ostomy bag. As the rings are mated with pressure applied the rings snap into mating connection with the plastic protruding ring surrounding the proximal wall stomal aperture. In a corresponding “one piece bag” the means for attachment of the bag directly to the body is an integral part of the bag. But for the thickness of the ring member or other attachment means, most currently available ostomy bags as viewed from an edge are approximately the thickness of a fine line drawn by a fine line pen. Accordingly, even though such bags are described in recent art as having “chambers,” until something enters the bag the chambers really are two face-to-face flat pieces of plastic sealed around their perimeter. From a word precision standpoint such bags could be said to be a “latent chamber” or have a “chamber precursor.” That is, (except where and to the extent the walls are sealed together and where appropriate port closure is provided) such bags have opposing walls that are readily separated from each other, for example, when gas, liquid and/or solids enter the bag. The result of the material entering the bag is to develop the three-dimensional character of the “chamber”, i.e. convert the chamber precursor into a chamber. This distinction has importance that will be discussed further below. For purposes of clarity, when the term “chamber” is used herein (unless otherwise indicated) the term is intended to include both “chamber precursor” and “chamber”.
The art generally refers to ostomy bags as one piece or two piece, and drainable or closed. Drainable ostomy bags usually have a narrowed, elongated portion ending in a discharge opening at the bottom of the bag. The narrowed, elongated portion accommodates closure members such as those described in U.S. Pat. No. 6,336,918. Such bags are normally closed by folding the narrowed portion over a blade of a removable closure device and forcing the blade and folded portion into a mating crevice in the device to form a gas and liquid impermeable closure. Closed bags have no opening at the end of the bag and are normally used in situations where the bag is either discarded after use or removed temporarily for washing.
Prior art devices have attempted to make the use of ostomy bags more comfortable to users, referred to herein as ostomists. One improvement that has been made, for example, is to include a comfort layer, a thin external layer of flexible, “breathable” fabric or thermoplastic covering the external surface of the proximal wall that would routinely come into contact with the body of the ostomist. Such a comfort layer reduces the discomfort of the plastic against skin feeling.
Many ostomists try to live a normal lifestyle and can, indeed, be very active. Nonetheless, even for those who are justifiably optimistic because they have beaten a deadly disease like colon cancer, problems persist. For example, for ostomists there is a whole new definition for the term “waste management!” Some of the most significant challenges ostomists face are associated with handling their personal day-to-day waste management chores and situations. Shortly after becoming one, an ostomist is quickly slapped in the face with first hand knowledge that some “natural products” are not pleasant, and that the smog index is not their most important air quality problem. The ostomist in public life has to be aware of his or her ostomy bag and the extent to which it is leaking its vile odors to the surrounds. Odor control or avoidance is still a major air quality challenge facing the ostomist, whether the ostomist is in a car pool, an office, an all day business meeting, a dinner party, or at home with the family! Controlling the problems associated with flatus gasses can be a particularly difficult challenge for those who still have a major portion of their small intestine but have had a significant portion of their large intestine removed. Evidently, because of the increased probability of flatulence and because the smell of the gas is extraordinarily foul, a number of attempts have been made to provide the ostomist confidence and comfort in controlling emission into and out of the ostomy bags. U.S. Pat. No. 6,135,986 ('986), for example, describes a number of prior art attempts to include filters and venting systems to deal with these problems. The patent (986) also outlines shortcomings of those prior art attempts. Those prior art attempts offer some improvements for both drainable and closed ostomy bags. The proposed solutions come in a wide variety of alternatives, for example, of filtering devices. However, problems still exist. Convenience, comfort, confidence and reasonable cost are extremely important for the ostomist. Filter mechanisms get clogged, resulting in bags becoming precariously expanded or, the filters get bi-passed. Even filters placed in the upper extremity of bags tend to get clogged. When ostomists are lying down or even in a sitting position, fecal emission collects around the stoma and can plug tiny holes used in a number of prior art filter systems. Those using gas permeable membranes are particularly susceptible to this type of clogging. If the filters do not operate effectively to allow the gasses to pass through them and deodorize that gas, the filters either emit their horrible odors or inhibit gas flow causing the bag to inflate. The latter can cause leakage of gas through the otherwise reasonably secure ring “seal” connecting the bag to the wafer, or can even cause the ring seals to disconnect, and the bag to pop off the wafer. The result is the release of foul smelling flatus gas, or worse! In addition, the solutions offered in the prior art (including in the '986 patent) tend to be relatively expensive. This is a critical factor to most ostomists and their insurers.
Even though a major ongoing concern for the ostomist is associated with flatus gasses, using an ostomy bag with no filter is still the option of choice of many less than content ostomists. As indicated above, the no filter or plugged filter alternatives leave the ostomist with an uncomfortable and sometimes embarrassing need, that of manually venting (deflating) the bag. Manual venting systems described in the prior art, for example, those described in U.S. Pat. Nos. 5,693,035, and 2,054,535 tend to be somewhat cumbersome and costly, thus limiting their acceptance. Accordingly, manual venting is routinely accomplished by many ostomists through the sequential steps including: (a) seeking and finding a private location; (b) opening or raising a garment (thereby exposing the top of the wafer/bag ring connection); (c) opening the connection partially (thereby breaking the original seal between the bag ring and the wafer ring; (d) applying slight pressure on the bag to release the gas into the atmosphere; (e) snapping the connection into complete closure; and, then (f) flapping the garment to fan the odor away. However, the odor is not one to release in a friend's bathroom! Even very strong bathroom ventilators are inadequate to deal with the penetrating and lasting odor. “Experts” have suggested lighting matches or candles. They help, but not adequately, and not at all in “no smoking” public toilet areas. Then there is the problem with the odor being retained in or on an undergarment, or the flapped garment. Also, periodically breaking the seal between the wafer and bag rings can result in a weakened seal or fecal material finding its way into the seal junction thereby increasing the risk of odor leak through the seal. Odor control agents (odor counteractants) applied in the bags tend to be messy and insufficiently effective and, therefore, do not solve the problems. Thus, many ostomists choose the no filter option with no built in vent system simply because there is not an attractive cost- or functionally-effective alternative. Some ostomists even choose fasting before a social event and/or avoidance of socialization to avoid creating uncomfortable situations for others and personal embarrassment. That, too, is not practical in the real, everyday work world.
One of the more distasteful, regular routines that many ostomists are confronted with is that of emptying the ostomy bag. This procedure puts the ostomist's nose in much closer proximity to his or her waste than any would like, and closer than most any non-ostomist would tolerate. There is a need to pay close attention to what one is doing in the emptying process, or such waste can find its way to many more places than anyone would like. There have been apparatus and techniques for facilitating bag cleaning disclosed in the prior art, which would help increase the nose/waste distance. (See, for example, U.S. Pat. No. 5,470,325 and references cited therein.) However, these have tended to add significant additional cost, and prior art cleaning devices (such as are described in U.S. Pat. Nos. 6,532,971, 5,083,580 and 5,037,408) generally would be cumbersome to make available outside the ostomist's home bathroom and/or add distasteful steps to the ostomist's routine. Some of the smell is associated with the emptying of drainable bags and especially the cleaning of the drainage channel after emptying.
The ostomist in need of deflation is pushed by the above challenges in the direction of interrupting normal activities and finding seclusion to go through the steps indicated above to minimize, and hopefully avoid, discomfort and embarrassment from escaping odors, fluids, and/or solids. Ostomists are left wanting for an ideal system for handling their ostomic environment (that is, the odors, the discharges, the discomfort, the appearance, the inconvenience, and the health issues) to minimize the negatives for their friends, family and associates, while being thankful that the surgery that created their ostomy likely saved their life.